- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004848
Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes (HEED)
Collaborations for Health Improvement in East Harlem-Project HEED
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Weight loss can prevent diabetes and eliminate racial and ethnic disparities in incident diabetes among overweight adults with pre-diabetes. However, proven effective interventions have not been sustained or disseminated in community settings. A community-academic partnership aims to employ community-based participatory research to conduct a randomized controlled trial to test the effectiveness of a culturally tailored, peer-led diabetes prevention intervention that promotes weight loss.
People who develop diabetes go through a period when they have "pre-diabetes". In clinical settings, overweight adults with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes by 55-60%. To date, there are no studies testing the effectiveness of peer-led, community-based programs in achieving diabetes prevention through weight loss.
We will identify and enroll 400 overweight (BMI > 25) adults with pre-diabetes in East Harlem and randomized half into a community-based, peer-led lifestyle education program that teaches simple ways to lose weight.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age and older
- Residents of East Harlem or members of an East Harlem Institution in zip codes 10029, 10035, OR in the section of 10037 east of Fifth Avenue
- BMI ≥ 25 AND pre-diabetes glucose values, defined as fasting fingerstick glucose of 100-125mg/dl and/or glucose 2 hours after an oral glucose load of 140-199 mg/dl
- Able to communicate verbally to participate in a group education class
- English or Spanish speaking
Exclusion Criteria:
- < 18 years
- Previous diagnosis of diabetes
- BMI <25
- Fingerstick glucoses outside pre-diabetes level ranges
- Currently pregnant
- On medications that may raise or lower blood glucose
- Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak)
- Self-reported terminal illness with life expectancy of less than 1 year
- Plans to relocate from New York City within one year of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Peer-Led Lifestyle Education on Weight Loss
Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes. The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes. |
Project HEED (Help Educate to Eliminate Diabetes) is a bilingual lifestyle education program written at a 4th grade reading level, and contains simple, actionable, messages, is easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes.
It consists of 8 sessions (1½ hours each) held over 10-weeks.
Topics include diabetes prevention, finding and affording healthy foods, label reading, fun physical activity, planning a healthy plate, making traditional foods healthy, and portion control.
Other Names:
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PLACEBO_COMPARATOR: Delayed Intervention
The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
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Project HEED (Help Educate to Eliminate Diabetes) is a bilingual lifestyle education program written at a 4th grade reading level, and contains simple, actionable, messages, is easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes.
It consists of 8 sessions (1½ hours each) held over 10-weeks.
Topics include diabetes prevention, finding and affording healthy foods, label reading, fun physical activity, planning a healthy plate, making traditional foods healthy, and portion control.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Weight From Baseline to 6 Months
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months
Time Frame: Change from Baseline to 6 Months
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Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline
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Change from Baseline to 6 Months
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Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months
Time Frame: Change in 6 Months from Baseline
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Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline
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Change in 6 Months from Baseline
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Change in Systolic Blood Pressure From Baseline to 6 Months
Time Frame: Change from Baseline to 6 Months
|
Change from Baseline to 6 Months
|
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Change in Diastolic Blood Pressure From Baseline to 6 Months
Time Frame: Change from Baseline to 6 Months
|
Change from Baseline to 6 Months
|
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Waist Circumference
Time Frame: Change from Baseline to 6 Months
|
Change from Baseline to 6 Months
|
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LDL Cholesterol
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
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HDL Cholesterol
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
|
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Total Cholesterol
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
|
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Triglycerides
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
|
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HbA1c
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
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Energy Expenditure
Time Frame: Change from Baseline to 6 Months
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percent energy expenditure
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Change from Baseline to 6 Months
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Fiber Intake
Time Frame: Change from Baseline to 6 Months
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Change from Baseline to 6 Months
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Physical Activity (Self-report)
Time Frame: 6 months
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6 months
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Knowledge & Attitudes About Diabetes Risk
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Goldfinger JZ, Arniella G, Wylie-Rosett J, Horowitz CR. Project HEAL: peer education leads to weight loss in Harlem. J Health Care Poor Underserved. 2008 Feb;19(1):180-92. doi: 10.1353/hpu.2008.0016.
- Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. doi: 10.2337/dc08-1296. Epub 2008 Nov 18. Erratum In: Diabetes Care. 2011 Oct;34(10):2338.
- Cowie CC, Rust KF, Byrd-Holt DD, Eberhardt MS, Flegal KM, Engelgau MM, Saydah SH, Williams DE, Geiss LS, Gregg EW. Prevalence of diabetes and impaired fasting glucose in adults in the U.S. population: National Health And Nutrition Examination Survey 1999-2002. Diabetes Care. 2006 Jun;29(6):1263-8. doi: 10.2337/dc06-0062.
- Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006 Sep;29(9):2102-7. doi: 10.2337/dc06-0560.
- Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.
- Biuso TJ, Butterworth S, Linden A. A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions. Dis Manag. 2007 Feb;10(1):6-15. doi: 10.1089/dis.2006.628.
- Horowitz CR, Brenner BL, Lachapelle S, Amara DA, Arniella G. Effective recruitment of minority populations through community-led strategies. Am J Prev Med. 2009 Dec;37(6 Suppl 1):S195-200. doi: 10.1016/j.amepre.2009.08.006.
- Fox AM, Mann DM, Ramos MA, Kleinman LC, Horowitz CR. Barriers to physical activity in East harlem, new york. J Obes. 2012;2012:719140. doi: 10.1155/2012/719140. Epub 2012 Jul 12.
- Fei K, Fox A, Horowitz CR, Lee E. Family History and Perceptions of Control over Risk for Diabetes, SGIM Supplement 2012. PMC Journal - In Process.
- Breland JY, Fox AM, Horowitz CR, Leventhal H. Applying a common-sense approach to fighting obesity. J Obes. 2012;2012:710427. doi: 10.1155/2012/710427. Epub 2012 Jun 28.
- Parikh P, Simon EP, Fei K, Looker H, Goytia C, Horowitz CR. Results of a pilot diabetes prevention intervention in East Harlem, New York City: Project HEED. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S232-9. doi: 10.2105/AJPH.2009.170910. Epub 2010 Feb 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 05-0463
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